Robert M Feldman1, Gregory Katz2, Matthew McMenemy3, Douglas A Hubatsch4, Tony Realini5. 1. Robert Cizik Eye Clinic, Ruiz Department of Ophthalmology and Visual Sciences, McGovern Medical School at The University of Texas Health Science Center (UTHealth), Houston, Texas. Electronic address: robert.m.feldman@uth.tmc.edu. 2. Department of Ophthalmology, St. Joseph Mercy Medical Center, Ann Arbor, Michigan. 3. Lone Star Eye Care, PA, Sugar Land, Texas. 4. Alcon Laboratories, Inc, Fort Worth, Texas. 5. Department of Ophthalmology, West Virginia University, Morgantown, West Virginia.
Abstract
PURPOSE: To evaluate the safety and efficacy of adding fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) as adjunctive therapy to travoprost 0.004% (TRAV) in patients with open-angle glaucoma or ocular hypertension. DESIGN: Multicenter, randomized, double-masked, parallel-group phase 4 clinical trial. METHODS: setting: Multicenter; 32 sites in the United States. PATIENT POPULATION: Total of 233 patients with open-angle glaucoma or ocular hypertension and with mean intraocular pressure (IOP) ≥21 mm Hg and <32 mm Hg while receiving once-daily TRAV monotherapy. INTERVENTION: Masked BBFC or vehicle (3 times daily) adjunctive to TRAV for 6 weeks. MAIN OUTCOME MEASURE: Mean diurnal IOP averaged over 8 AM, 10 AM, 3 PM, and 5 PM time points at week 6. Superiority of BBFC+TRAV over vehicle+TRAV was based on statistical significance of a treatment difference favoring BBFC+TRAV. RESULTS:Mean diurnal IOP at week 6 (least squares mean ± standard error) was 17.6 ± 0.4 mm Hg and 20.7 ± 0.4 mm Hg in the BBFC+TRAV and vehicle+TRAV groups, respectively (between-group difference, -3.2 ± 0.5 mm Hg; P < .0001). Superiority of BBFC+TRAV over vehicle+TRAV was established. Mean and percent diurnal IOP change from baseline were significantly greater with BBFC+TRAV compared with vehicle+TRAV (P < .0001 for both). Conjunctival hyperemia was the most common treatment-related adverse event in either group (BBFC+TRAV, 12.8%; vehicle+TRAV, 6.0%). CONCLUSIONS: Adjunctive treatment with BBFC added to TRAV resulted in lower mean diurnal IOP after 6 weeks of treatment compared with vehicle added to TRAV; this difference was both statistically and clinically significant.
RCT Entities:
PURPOSE: To evaluate the safety and efficacy of adding fixed-combination brinzolamide 1%/brimonidine 0.2% (BBFC) as adjunctive therapy to travoprost 0.004% (TRAV) in patients with open-angle glaucoma or ocular hypertension. DESIGN: Multicenter, randomized, double-masked, parallel-group phase 4 clinical trial. METHODS: setting: Multicenter; 32 sites in the United States. PATIENT POPULATION: Total of 233 patients with open-angle glaucoma or ocular hypertension and with mean intraocular pressure (IOP) ≥21 mm Hg and <32 mm Hg while receiving once-daily TRAV monotherapy. INTERVENTION: Masked BBFC or vehicle (3 times daily) adjunctive to TRAV for 6 weeks. MAIN OUTCOME MEASURE: Mean diurnal IOP averaged over 8 AM, 10 AM, 3 PM, and 5 PM time points at week 6. Superiority of BBFC+TRAV over vehicle+TRAV was based on statistical significance of a treatment difference favoring BBFC+TRAV. RESULTS: Mean diurnal IOP at week 6 (least squares mean ± standard error) was 17.6 ± 0.4 mm Hg and 20.7 ± 0.4 mm Hg in the BBFC+TRAV and vehicle+TRAV groups, respectively (between-group difference, -3.2 ± 0.5 mm Hg; P < .0001). Superiority of BBFC+TRAV over vehicle+TRAV was established. Mean and percent diurnal IOP change from baseline were significantly greater with BBFC+TRAV compared with vehicle+TRAV (P < .0001 for both). Conjunctival hyperemia was the most common treatment-related adverse event in either group (BBFC+TRAV, 12.8%; vehicle+TRAV, 6.0%). CONCLUSIONS: Adjunctive treatment with BBFC added to TRAV resulted in lower mean diurnal IOP after 6 weeks of treatment compared with vehicle added to TRAV; this difference was both statistically and clinically significant.
Authors: Swaantje Grisanti; Salvatore Grisanti; Julian Garcia-Feijoo; H Burkhard Dick; Francisco Jose Munoz-Negrete; Elena Arrondo; Tsontcho Ianchulev Journal: BMJ Open Ophthalmol Date: 2018-12-22